A Parallel, Randomised, Double Blind, Placebo Controlled Study to Investigate the Effect of NOGO on Overactive Bladder in Men and Women

SagaNatura1 site in 1 country200 target enrollmentMay 1, 2020

ConditionsOveractive Bladder Nocturia

Interventionsextract from Angelica archangelica leaf Placebo

Drugsextract from Angelica archangelica leaf Placebo

Overview

Phase: Phase 2
Intervention: extract from Angelica archangelica leaf
Conditions: Overactive Bladder
Sponsor: SagaNatura
Enrollment: 200
Locations: 1
Primary Endpoint: Reduction of urination frequency (number of voids per 24 hours)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a double-blind, randomized and placebo-controlled study to evaluate the safety and effectiveness of NoGo, a standardized extract from Angelica archangelica, on overactive bladder

Registry

clinicaltrials.gov

Start Date

May 1, 2020

End Date

March 1, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

SagaNatura

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Suspected or diagnosed with overactive bladder (average ≥ of 1.5 nocturnal voids per night and/or less then 2 hours between voids at least half time of the day (question 2 IPSS)

Exclusion Criteria

•High alcohol consumption (males \> 3 beers/day (36 g alcohol), females \>2 beers/day --
•(24 g alcohol), but we take weekly average.
•Abnormal urinary findings suggestive of urinary tract infection, significant hematuria or glucosuria requiring further evaluation.
•Chronic incontinence.
•Recurrent urinary tract infections (3 or more times per year).
•Pregnancy, lactation, last child born at least one year before, uterine prolapse, histerectomy
•Surgical treatment for bladder outlet obstruction/BPH performed within the past 6 months. Moderate to severe prostate hyperplasia (IPSS questionnaire).
•Medical history or active conditions which, in the opinion of the principal investigator (PI) and physicians participating in the study would prohibit participation in the study. This includes, but is not limited to: diabetes, cancer, renal failure, cirrhosis or chronic liver disease, pancreatic diseases, recent (\<6 months) myocardial infarction or unstable coronary artery disease.
•Psychiatric diseases and medication.
•Use of NoGO or other products containing A. archangelica extract within the previous 2 months prior to randomisation.

Arms & Interventions

Experimental

Intervention: extract from Angelica archangelica leaf

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Reduction of urination frequency (number of voids per 24 hours)

Time Frame: 6 weeks

Reduction in number of voids per 24 hours as assessed by a 3 day voiding diary before and after treatment

Secondary Outcomes

Reduced number of daytime voids(6 weeks)
Reduced number of nocturnal voids (nocturia)(6 weeks)
Reduced number of nocturnal voids (nocturia) per hour sleeping time(6 weeks)
Reduced number of voids occurring shortly after the last one(6 weeks)
Improvement of the results of the International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB)(6 weeks)
Improvement of the results of the The International Prostate Symptom Score (IPSS)(6 weeks)